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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02914353
Registration number
NCT02914353
Ethics application status
Date submitted
19/09/2016
Date registered
26/09/2016
Titles & IDs
Public title
Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety Tolerability, Pharmacokinetics, and Pharmacodynamcs of Single and Multiple Ascending Doses of EP-7041 in Hea;Thy Subjects
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Secondary ID [1]
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EXI-111
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EP=7041
Treatment: Drugs - Placebo
Experimental: Experimental - EP-7041 - Single Ascending Dose: Single IV dose for each cohort; dose range 0.01 mg/kg to 1.0 mg/kg
Multiple Ascending Dose: 0.01 mg/kg/h - 5 x 24 h continuous infusion up to 0.6 mg/kg/h - 5 x 24 h continuous infusion
Placebo comparator: Placebo - Sterile Saline - Single Ascending Dose: Single IV dose for each cohort;
Multiple Ascending Dose: 5 x 24 h continuous infusion for each cohort
Treatment: Drugs: EP=7041
Factor X!a Inhibitor
Treatment: Drugs: Placebo
Normal Saline
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a single IV bolus of EP-7041
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Assessment method [1]
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Assessment of safety and tolerability to EP-7041, administered as a single IV bolus, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a three-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the MedDRA (Medical Dictionary for Regulatory Activities) dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made.
The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity. If an AE is
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Timepoint [1]
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Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
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Primary outcome [2]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a continuous IV infusion of EP-7041 administered over 5 days
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Assessment method [2]
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Assessment of safety and tolerability to EP-7041, administered as a continuous IV infusion over 5 days, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a 3-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the Medical Dictionary for Regulatory Activities dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term.
The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity.
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Timepoint [2]
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Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
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Secondary outcome [1]
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Measurement of Maximum Plasma Concentration Achieved Following a Single IV Bolus of EP-7041
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Assessment method [1]
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Maximum Plasma Concentration (Cmax)
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Measurement of Time of Maximum Plasma Concentration Following a Single IV Bolus of EP-7041
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Assessment method [2]
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Time of Maximum Plasma Concentration (Tmax)
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Timepoint [2]
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24 hours
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Secondary outcome [3]
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Measurement of Plasma Half-Life Following a Single IV Bolus of EP-7041
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Assessment method [3]
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Plasma Half-Life (T½)
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Timepoint [3]
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24 hours
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Secondary outcome [4]
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Measurement of ClearanceFollowing a Single IV Bolus of EP-7041
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Assessment method [4]
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Clearance (CL)
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Timepoint [4]
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24 hours
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Secondary outcome [5]
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Measurement of the Area Under the Plasma Concentration versus Time Curve Following a Single IV Bolus of EP-7041
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Assessment method [5]
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Area Under the Curve (AUC)
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Timepoint [5]
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24 hours
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Secondary outcome [6]
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Measurement of the Elimination Rate Constant Following a Single IV Bolus of EP-7041
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Assessment method [6]
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Elimination Rate Constant (Kel)
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Timepoint [6]
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24 hours
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Secondary outcome [7]
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Measurement of the Apparent Volume of Distribution Following a Single IV Bolus of EP-7041
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Assessment method [7]
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Apparent Volume of Distribution (Vd)
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Timepoint [7]
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24 hours
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Secondary outcome [8]
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Measurement of the Steady-State Concentration with a the Initiation of Continuous IV 5-day Infusion of EP-7041
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Assessment method [8]
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Concentration at Steady State (Css)
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Timepoint [8]
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6 days
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Secondary outcome [9]
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Measurement of the Time to Reach a Steady-State Concentration Following a the Initiation of Continuous IV 5-day Infusion of EP-7041
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Assessment method [9]
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Time to Reach Concentration at Steady State (Tss)
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Timepoint [9]
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6 days
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Secondary outcome [10]
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Measurement of the Clearance During the Course of a Continuous IV 5-day Infusion of EP-7041
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Assessment method [10]
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Clearance (CL)
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Timepoint [10]
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6 days
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Secondary outcome [11]
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Measurement of the Plasma Half-Life Following the Discontinuation of Continuous IV 5-day Infusion of EP-7041
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Assessment method [11]
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Plasma Half-Life (T½)
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Timepoint [11]
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6 day
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Secondary outcome [12]
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Measurement of Clotting Biomarker Activated Partial Thromboplastin Time Following a Single IV Bolus of EP-7041
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Assessment method [12]
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Activated Partial Thromboplastin Time (aPTT)
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Timepoint [12]
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1 day
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Secondary outcome [13]
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Measurement of Clotting Biomarker Activated Partial Thromboplastin Time During the Course of a Continuous IV 5-day Infusion of EP-7041
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Assessment method [13]
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Activated Partial Thromboplastin Time (aPTT)
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Timepoint [13]
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6 days
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Secondary outcome [14]
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Measurement of Clotting Biomarker Prothrombin Following a Single IV Bolus of EP-7041
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Assessment method [14]
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Prothrombin Time (PT)
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Timepoint [14]
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1 day
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Secondary outcome [15]
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Measurement of Clotting Biomarker Prothrombin During the Course of a Continuous IV 5-day Infusion of EP-7041
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Assessment method [15]
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Prothrombin Time (PT)
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Timepoint [15]
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6 day
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Secondary outcome [16]
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Measurement of Clotting Biomarker International Normalized Ratio Following a Single IV Bolus of EP-7041
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Assessment method [16]
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International Normalized Ratio (INR)
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Timepoint [16]
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1 day
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Secondary outcome [17]
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Measurement of Clotting Biomarker International Normalized Ratio During the Course of a Continuous IV 5-day Infusion of EP-7041
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Assessment method [17]
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International Normalized Ratio (INR)
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Timepoint [17]
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6 days
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Eligibility
Key inclusion criteria
* Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), =18 and =60 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 and a weight of at least 60 kg but not greater than 100 kg.
* Healthy as defined by:
1. No history of abnormal bleeding episodes, e.g. nosebleeds, or abnormally heavy periods, or extensive bleeding after injury, surgery or dental work.
2. A normal short physical examination and normal vital signs (heart rate (HR), blood pressure (BP) and tympanic body temperature).
3. Normal laboratory tests (hematology, biochemistry, urinalysis, coagulation tests (aPTT and PT).
4. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
5. the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Any clinically significant abnormality or abnormal laboratory test results found during medical screening which, at the investigator's discretion, warrants exclusion or positive test for hepatitis B, hepatitis C, or HIV.
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration.
* Positive pregnancy test at screening or check-in (Day -1).
* Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening or check-in (Day -1).
* Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics), or five (5) half-lives, whichever is longer, prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
* Hemoglobin or hematocrit clinically significantly less than lower limits of normal at screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2017
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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IDT CMAX - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
eXIthera Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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IDT CMAX Clinical Trials
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Syneos Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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CPR Pharma Services Pty Ltd, Australia
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.
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Trial website
https://clinicaltrials.gov/study/NCT02914353
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sepehr Shakib, MD
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Address
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IDT CMAX
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02914353